Quality Manuals
QM-RI-1 – Research and Innovation Quality Manual
- Author Name: Paul Gribbon
- Version: 1.0
- Active Date: 09/11/2023
- Review Date: 31/12/2024
QM-IN-1 – Innovation Quality Manual
- Author Name: Elaine O’Neill
- Version: 1.0
- Active Date: 18/03/2024
- Review Date: 31/12/2025
QM-BIO-1 – Biorepository Quality Manual
- Author Name: Clare Orange
- Version: 1.1
- Active Date: 24/04/2024
- Review Date: 31/12/2025
QM-SH-1 – Safe Haven Quality Manual
- Author Name: Alison Hamilton
- Version: 1.0
- Active Date: 10/10/2023
- Review Date: 31/12/2024
Chapter 17 – NHS GG&C Clinical Research Facility – Clinical
SOP 17.001 – Adult Emergency Resuscitation Procedures in GCRF
- Author Name: Naomi Hickey
- Version: 5.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- Form 17.001A – GCRF Emergency Trolley Signoff
- Form 17.001B – GCRF QEUH Adult Emergency Trolley Checklist
- Form 17.001C – GCRF GRI Emergency Trolley Checklist
- Form 17.001D – GCRF GGH Emergency Trolley Checks
- Guideline 17.001A – GCRF Emergency Trolley Checks
- Guideline 17.001B – Psychiatric Emergency
SOP 17.003 – Research Participant’s Clinical Measurements
- Author Name: Karen Duffy
- Version: 5.0
- Active Date: 18/10/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 17.005 – Urinalysis
- Author Name: Linda Wilson
- Version: 4.0
- Active Date: 23/06/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 17.006 – Refrigerator and Freezer Unit Use and Monitoring
- Author Name: Barbara McLaren
- Version: 5.0
- Active Date: 04/01/2025
- Review Date: 31/12/2028
Associated Documents
- Guideline 17.006A – Out of Hours Fridge and Freezer Alert
- Guideline 17.006B – GCRF Kelsius Fridge/Freezer Management System
- Guideline 17.006C – GCRF Checkit Fridge/Freezer Management System
SOP 17.007 – Use of laboratory centrifuge
- Author Name: Dominic Rimmer
- Version: 5.0
- Active Date: 23/06/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 17.008 – Recording an Electrocardiograph (ECG)
- Author Name: Barbara McLaren
- Version: 5.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 17.009 – Obtaining Spirometry Measurements
- Author Name: Hilary Peddie
- Version: 5.0
- Active Date: 27/09/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 17.012 – Obtaining Informed Consent (Adults)
- Author Name: Helen Hart
- Version: 6.0
- Active Date: 28/09/2022
- Review Date: 31/12/2025
Associated Documents
- Guideline 17.012A – Remote Consent
SOP 17.013 – Study Site Coordination and Delivery of an ATIMP Study
- Author Name: Karen Duffy
- Version: 1.0
- Active Date: 20/12/2019
- Review Date: 31/12/2023
Associated Documents
- Form 17.013A – Clinical Alert Template for Genetically Modified Advanced Therapy IMP
- Form 17.013B – Inter-site Communication Form for Genetically Modified Advanced Therapy IMP Delivery
SOP 17.015 – Measurement of Pulse Wave Analysis (PWA) and Pulse Wave Velocity (PWV)
- Author Name: Barbara McLaren
- Version: 5.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 17.016 – Ambulatory Electrocardiograph Monitoring
- Author Name: Karen Duffy
- Version: 4.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 17.020 – Monitoring Expiration of Clinical Consumables
- Author Name: Barbara McLaren
- Version: 4.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- Form 17.020A – Glasgow Clinical Research Facility Consumable Checklist
SOP 17.025 – Initialising the 24 hour BP monitor
- Author Name: Barbara McLaren
- Version: 4.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 17.026 – Use of Ambulatory Blood Pressure Monitoring Machines
- Author Name: Barbara McLaren
- Version: 4.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 17.027 – Role of GCRF Nurse Coordinator
- Author Name: Naomi Hickey
- Version: 2.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- Form 17.027A – Nurse Coordinator Checks
SOP 17.028 – Management of Hypoglycaemia in adults
- Author Name: Hilary Peddie
- Version: 4.0
- Active Date: 21/07/2023
- Review Date: 31/12/2026
Associated Documents
- Form 17.028A – GCRF Blood Glucose Hypo Kit Checklist
SOP 17.029 – Management of Anaphylaxis in Adults and Paediatrics
- Author Name: Naomi Hickey
- Version: 4.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 17.030 – Measuring and Recording Blood Pressure using digital or electronic equipment
- Author Name: Karen Duffy
- Version: 4.0
- Active Date: 24/11/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 17.032 – Return of stock drugs and IMPs
- Author Name: Barbara McLaren
- Version: 4.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- Form 17.032A – Glasgow Clinical Research Facility Spot Check Rota
SOP 17.034 – Storage and management of Medication
- Author Name: Dominic Rimmer
- Version: 5.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- Form 17.034A – GCRF Drug Cupboard Weekly Checklist
- Form 17.034B – Nurse Manager Drug Cupboard Spot Check
SOP 17.035 – Administration of a Vaccine
- Author Name: AnneMarie Munro
- Version: 2.0
- Active Date: 25/10/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 17.041 – GCRF Management of Samples
- Author Name: Barbara McLaren
- Version: 2.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- Form 17.041A – Sample Log
- Form 17.041B – Fridge and Freezer Planner
SOP 17.042 – Paediatric Emergency Resuscitation Procedures in GCRF
- Author Name: Susanne Cathcart
- Version: 4.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- Form 17.042A – GCRF QEUH Paediatric Emergency Trolley Checklist
SOP 17.044 – NHS Research Scotland Children s Network SOPs in GCRF
- Author Name: Susanne Cathcart
- Version: 3.0
- Active Date: 29/08/2019
- Review Date: 31/12/2026
Associated Documents
- Guideline 17.044A – Paediatric Insertion of a Peripheral Venous Catheter
SOP 17.045 – Case Report Form (CRF) Completion
- Author Name: Dominic Rimmer
- Version: 4.0
- Active Date: 23/06/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 17.047 – Transfer of the Unwell Research Participant to Acute Care
- Author Name: Steven Henderson
- Version: 2.0
- Active Date: 23/06/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 17.048 – GCRF Risk Assessment and Mitigation
- Author Name: Karen Duffy
- Version: 3.0
- Active Date: 09/04/2023
- Review Date: 31/12/2026
Associated Documents
- Form 17.048A – GCRF Study Risk Assessment Form
SOP 17.052 – Grantbio Shaker-Incubator
- Author Name: Shona Perry
- Version: 2.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 17.053 – Blood Sampling from a Peripheral Venous Catheter
- Author Name: Naomi Hickey
- Version: 2.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 17.055 – Obtaining Informed Consent and Assent (Children)
- Author Name: Naomi Hickey
- Version: 1.0
- Active Date: 02/03/2023
- Review Date: 31/12/2026
Associated Documents
- None
Chapter 21 – NHS GG&C Pharmacy – Sponsor IMP Management
SOP 21.001 – Review of grant applications with respect to IMP manufacture, distribution and management
- Author Name: Elizabeth Douglas
- Version: 3.0
- Active Date: 26/09/2023
- Review Date: 31/12/2026
Associated Documents
- Form 21.001A – Summary of Pharmacy and IMP Related Costs (Grants/Support)
- Form 21.001B – Template Specification for IMP Manufacturing Activity
- Guideline 21.001A – Generating anticipated pharmacy and IMP related study costs
SOP 21.003 – Sponsor IMP Management and Accountability
- Author Name: Pamela Surtees
- Version: 5.0
- Active Date: 26/09/2023
- Review Date: 31/12/2026
Associated Documents
- Form 21.003A – NHS GG&C Sponsored/Co-sponsored Clinical Trials Checklist: Site IMP Management & Accountability Manuals
- Form 21.003B – NHS GG&C Sponsored/Co-Sponsored Clinical Trials Checklist: Sponsor IMP Management & Accountability Manuals
- Form 21.003C – IMP Management File Note
- Form 21.003D – NHS GG&C Sponsored/Co-sponsored Clinical Trials Checklist:
- Form 21.003E – NHS GG&C Sponsored/Co-sponsored Clinical Trials Checklist:
- Guideline 21.003A – IMP Management and Accountability Processes and Documentation
- Guideline 21.003B – IMP /Study Product management and accountability processes and documentation for Investigator site file
SOP 21.004 – Sponsor Management of IMPs Permanently Stored External to Pharmacy
- Author Name: Paula Morrison
- Version: 2.0
- Active Date: 31/03/2025
- Review Date: 31/12/2028
Associated Documents
- Form 21.004A – Sponsor IMP Management Risk Assessment Process: Permanent Storage of IMP External to Pharmacy
- Form 21.004B – IMP Storage Assessment – Permanent Storage of IMP External to Pharmacy
- Guideline 21.004A – Permanent Storage of IMPs External to Pharmacy: Guidance on Risk Mitigation Strategies
SOP 21.005 – Managing Drug Alerts and Other Urgent Defective Medicine Reports for IMPs and NIMPs in Clinical Trials Sponsored or Co-Sponsored by NHS GG&C
- Author Name: Elizabeth Douglas
- Version: 4.0
- Active Date: 28/09/2023
- Review Date: 31/12/2026
Associated Documents
- Form 21.005A – Defective Medicines Alert Tracker for Sponsored/Co-sponsored by NHS GG&C
SOP 21.007 – Site-to-site transfer of Investigational Medicinal Products
- Author Name: Elizabeth Douglas
- Version: 3.0
- Active Date: 28/09/2023
- Review Date: 31/12/2026
Associated Documents
- Form 21.007A – IMP Site-to-Site Risk Assessment Form
- Form 21.007B – IMP Site-to-Site Transfer Form
SOP 21.008 – Development and approval of labelling text for IMPs and NIMPs
- Author Name: Pamela Surtees
- Version: 4.0
- Active Date: 10/12/2023
- Review Date: 31/12/2026
Associated Documents
- Form 21.008A – NHS GG&C IMP Label Specification Sponsor Approval Form
SOP 21.009 – Expiry Date Monitoring for Study Products Supplied as Part of a Clinical Trial
- Author Name: Pamela Surtees
- Version: 4.0
- Active Date: 10/12/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 21.010 – Disposal of Investigational Medicinal Products and other study products
- Author Name: Pamela Surtees
- Version: 4.0
- Active Date: 10/12/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 21.011 – Management of temperature deviations and defects in IMPs and NIMPs supplied by Sponsor for clinical trials sponsored or co-sponsored by NHSGGC
- Author Name: Paula Morrison
- Version: 4.0
- Active Date: 26/09/2023
- Review Date: 31/12/2026
Associated Documents
- Form 21.011A – IMP Temperature Deviation & Defect Reporting Form
- Form 21.011B – Template Defective IMP/NIMP Report
- Guideline 21.011A – Guideline on management of IMP and NIMP quality defects
SOP 21.012 – R&I Pharmacy Review Of Sponsored Clinical Trials
- Author Name: Elizabeth Douglas
- Version: 4.0
- Active Date: 10/12/2023
- Review Date: 31/12/2026
Associated Documents
- Form 21.012A – Technical Agreement, Contract and Work Order Checklist for delegation of IMP responsibilities
- Form 21.012B – R&I Pharmacy Task Tracker
- Form 21.012C – Sponsor Risk Assessment for IMP Delivery from Participating Study Site to Participant s Home
- Guideline 21.012A – R&I pharmacy review of sponsored clinical trials
SOP 21.013 – Testing of Emergency Unblinding System for Blinded research
- Author Name: Elizabeth Douglas
- Version: 3.0
- Active Date: 20/12/2023
- Review Date: 31/12/2026
Associated Documents
- Form 21.013A – Emergency Unblinding Test Plan (Non-Automated Process)
- Form 21.013B – Record of IVRS/IWRS systems review for emergency unblinding
SOP 21.014 – Sponsor Investigational Medicinal Product Management Document Control Process
- Author Name: Paula Morrison
- Version: 4.0
- Active Date: 20/12/2023
- Review Date: 31/12/2026
Associated Documents
- Form 21.014A – Sponsor Pharmacy Investigational Medicinal Product (IMP) Management Document Control Log
SOP 21.016 – R&I Pharmacy Site Initiation Training
- Author Name: Pamela Surtees
- Version: 2.0
- Active Date: 20/12/2023
- Review Date: 31/12/2026
Associated Documents
- Form 21.016A – NHS GG&C Sponsored/Co-sponsored Study product Checklist: Site Pharmacy Initiation Training Form
- Guideline 21.016A – R&I Pharmacy Study Product Management Training for sites
SOP 21.017 – Regulatory approval of IBs not submitted for approval by commercial partner
- Author Name: Paula Morrison
- Version: 2.0
- Active Date: 20/12/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 21.018 – Sponsor Pharmacy Review of Study Amendments
- Author Name: Angela Carruth
- Version: 2.0
- Active Date: 25/01/2024
- Review Date: 31/12/2027
Associated Documents
- Guideline 21.018A – Sponsor Pharmacy & Local Pharmacy Review of Study Amendments
SOP 21.019 – Reconciliation of Study Product at site or study close out
- Author Name: Pamela Surtees
- Version: 2.0
- Active Date: 20/12/2023
- Review Date: 31/12/2026
Associated Documents
- Form 21.019A – Pharmacy Study Product Reconciliation Check
SOP 21.020 – Periodic review/end of Trial Management File check for studies Sponsored, Co-Sponsored or facilitated by NHSGGC
- Author Name: Pamela Surtees
- Version: 2.0
- Active Date: 20/12/2023
- Review Date: 31/12/2026
Associated Documents
- Form 21.020A – Checklist for periodic review/end of trial TMF(Section 10) check for studies Sponsored, Co-Sponsored or facilitated by NHSGGC
SOP 21.023 – IVRS/IWRS IMP management specification development, testing & training
- Author Name: Elizabeth Douglas
- Version: 2.0
- Active Date: 20/12/2023
- Review Date: 31/12/2026
Associated Documents
- Form 21.023A – IVRS/IWRS Specification for Drug Supply Management System(s)
- Form 21.023B – IXRS Drug Supply Management Acceptance Testing Approval & Training
- Form 21.023C – IXRS User Acceptance Testing Tracker
SOP 21.024 – Management of shelf-life extension for IMPs for research Sponsored by NHSGGC or Co-Sponsored by NHSGGC & UoG or when NHSGGC are UK Lead or Coordinating Centre for another Sponsor
- Author Name: Elizabeth Douglas
- Version: 1.0
- Active Date: 20/12/2023
- Review Date: 31/12/2026
Associated Documents
- Form 21.024A – Site IMP Labelling Form
- Guideline 21.024A – Detailed guidance on IMP date extension process for research Sponsored by NHSGGC or Co-Sponsored by NHSGGC & UoG or when NHSGGC are UK Lead or Coordinating Centre for another Sponsor
SOP 21.025 – Management of Dose Escalation in Early Phase IMP/ATIMP Clinical Trials
- Author Name: Elizabeth Douglas
- Version: 2.0
- Active Date: 26/05/2025
- Review Date: 31/12/2028
Associated Documents
- Form 21.025A – Cohort Management Form
- Form 21.025B – Dose Escalation Operational Plan
- Form 21.025C – Safety Review Charter
- Form 21.025D – Safety Review Committee Meeting Agenda
- Form 21.025E – Safety Review Committee Minute
- Form 21.025F – Robertson Centre for Biostatistics Cohort Decision Form
- Form 21.025G – Green to Dose Checklist
Chapter 22 – NHS GG&C Pharmacy – Hosted CTIMP
SOP 22.001 – Defects in Clinical Trial Supplies
- Author Name: Maria Nygren
- Version: 4.0
- Active Date: 17/05/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.002 – Recall of Clinical Trial Supplies
- Author Name: Maria Nygren
- Version: 4.0
- Active Date: 17/05/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.003 – Clinical Trial Training for Pharmacy Staff
- Author Name: Maria Nygren
- Version: 4.0
- Active Date: 17/05/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.006 – Development and maintenance of the Pharmacy Dispensing and Study Management Procedure for studies hosted by NHSGGC
- Author Name: Maria Nygren
- Version: 5.0
- Active Date: 17/05/2024
- Review Date: 31/12/2027
Associated Documents
- Form 22.006A – Pharmacy Dispensing & Study Management Procedure
- Form 22.006B – Pharmacy Dispensing and Study Management Procedure Change Control Log
SOP 22.007 – Receipt and release of IMPs and NIMPs on delivery to pharmacy sites
- Author Name: Maria Nygren
- Version: 7.0
- Active Date: 25/11/2024
- Review Date: 31/12/2027
Associated Documents
- Form 22.007A – IMP Quarantine and Tracking Release record (Pharmacy – Excluding New Deliveries)
- Form 22.007B – Storage Location Log (Pharmacy)
- Form 22.007C – IMP Quarantine Release Record (Pharmacy New deliveries only)
SOP 22.008 – Temperature monitoring for IMPs and other medicines involved in research
- Author Name: Eliza Valentine
- Version: 6.0
- Active Date: 06/07/2024
- Review Date: 31/12/2027
Associated Documents
- Form 22.008A – Clinical Trials Temperature Monitoring Record (Ambient Temperature)
- Form 22.008B – Temperature Deviation Alert Summary
- Form 22.008C – Annual Temperature Mapping Exercise
- Form 22.008D – Commissioning Temperature Mapping Exercise
- Guideline 22.008A – Environmental monitoring for IMPs and other medicines involved in research: temperature monitoring
- Guideline 22.008B – Standards for Refrigerators and Freezers and Temperature Monitoring Equipment for Clinical Trials
- Guideline 22.008C – Temperature Mapping for Refrigerators and Freezers used to Store IMPs and Other Medicines Involved in Research
- Guideline 22.008D – Kelsius Temperature Monitoring System
- Guideline 22.008E – Process for configuring data loggers for mapping and commissioning of refrigerators and freezers and monitoring temperatures external to pharmacy
SOP 22.009 – Dispensing and accuracy checking for clinical trial supplies
- Author Name: Jennifer McAughtrie
- Version: 4.0
- Active Date: 26/05/2022
- Review Date: 31/12/2027
Associated Documents
- Form 22.009A – Pharmacy Study Specific Training Record
- Form 22.009B – Pharmacy Subject Identification Log
- Form 22.009C – Pharmacy Clinical Trial Supply Collection log
- Guideline 22.009A – dispensing and accuracy checking for clinical trial supplies
SOP 22.010 – Managing participant returns for clinical trials
- Author Name: Maria Nygren
- Version: 5.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- Form 22.010A – Pharmacy Clinical Trial Returned Medication Log
SOP 22.011 – Disposal and destruction of clinical trial related pharmaceutical waste
- Author Name: Maria Nygren
- Version: 5.0
- Active Date: 06/07/2024
- Review Date: 31/12/2027
Associated Documents
- Form 22.011A – Destruction of clinical trial supplies log (Pharmacy)
- Form 22.011B – NHSGGC Statement of clinical trial supplies destruction policy
- Form 22.011C – Clinical Trials Supplies Returns to Sponsor Log (Pharmacy)
- Guideline 22.011A – Disposal of clinical trial drugs back to Sponsor
- Guideline 22.011B – Destruction of clinical trial related pharmaceutical waste
SOP 22.012 – Emergency unblinding of treatment allocation in clinical trials
- Author Name: Ramis Qureshi
- Version: 4.0
- Active Date: 06/07/2024
- Review Date: 31/12/2027
Associated Documents
- Form 22.012A – Emergency Unblinding of Assigned Treatment
SOP 22.013 – Managing storage of IMPs and NIMPs external to pharmacy
- Author Name: Sharon Grant
- Version: 7.0
- Active Date: 06/07/2024
- Review Date: 31/12/2027
Associated Documents
- Form 22.013A – Assessment to Support IMP Management External to Pharmacy
- Form 22.013B – Local procedures for the management of IMPS and other medicines as part of a clinical trial
- Guideline 22.013A – Short term and long term management of IMPs and NIMPs external to pharmacy
SOP 22.014 – Transfer of IMPs/NIMPs in clinical trials
- Author Name: Sharon Grant
- Version: 5.0
- Active Date: 06/07/2024
- Review Date: 31/12/2027
Associated Documents
- Form 22.014A – Shipment notice for Clinical Trial Supplies transfer
- Guideline 22.014A – Transfer of IMPs/NIMPs in clinical trials
SOP 22.015 – Continuous pharmaceutical input to research involving medicines
- Author Name: Jennifer McAughtrie
- Version: 4.0
- Active Date: 06/07/2024
- Review Date: 31/12/2027
Associated Documents
- Form 22.015A – Pharmacy File Note
SOP 22.016 – NHSGGC Pharmacy Clinical Trials Site File
- Author Name: Kirsty McLeish
- Version: 3.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- Form 22.016A – NHSGGC Generic Pharmacy Site File Index
- Form 22.016B – NHSGGC Aseptic Generic Pharmacy Site File Index
- Form 22.016C – Pharmacy Site File Set-Up Checklist
SOP 22.020 – Collation of workload information for pharmacy clinical trials services in NHSGGC
- Author Name: Kirsty McLeish
- Version: 4.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.021 – Pharmacy authorisation process for clinical trials hosted by NHSGGC
- Author Name: Kirsty McLeish
- Version: 5.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- Form 22.021A – Pharmacy-Finance Form for Non-Commercial Research
- Guideline 22.021A – Pharmacy authorisation process for clinical trials
- Guideline 22.021B – Pharmacy actions on notification of a new study
SOP 22.022 – Pharmacy review of clinical trials hosted by NHSGGC
- Author Name: Kirsty McLeish
- Version: 5.0
- Active Date: 21/06/2024
- Review Date: 31/12/2027
Associated Documents
- Form 22.022A – Pharmacy Clinical trials set-up tracking form
- Form 22.022B – Checklist for Pharmacy Review of Study Protocol for Clinical Trials hosted by NHSGGC
- Form 22.022C – Key Sponsor and Local Study Contacts for Pharmacy
- Form 22.022D – NHSGGC Clinical Trials Pharmacy Pro-forma
- Form 22.022G – Prescription Form
- Form 22.022H – Master Site Level Accountability Log
- Guideline 22.022A – Process for Pharmacy Review of Studies hosted by NHSGGC
- Guideline 22.022B – Documentation Review and Requirements for Clinical Trials that are Hosted within NHSGGC
SOP 22.023 – Re-labelling of clinical trial medicines for expiry date extension
- Author Name: Linda Taylor
- Version: 4.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- Guideline 22.023A – Relabelling for Expiry Date Extension
SOP 22.024 – Use of hospital stock for clinical trials
- Author Name: Sharon Grant
- Version: 4.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.025 – Expiry date monitoring of clinical trial medicines
- Author Name: Ramis Qureshi
- Version: 6.0
- Active Date: 26/02/2025
- Review Date: 31/12/2028
Associated Documents
- Form 22.025C – Expiry Spreadsheet
SOP 22.026 – Closure of a clinical trial pharmacy process
- Author Name: Karen Montgomery
- Version: 5.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- Form 22.026A – Pharmacy Tracking Form for Study Closure
- Form 22.026B – Pharmacy Clinical Trials Archive Form
SOP 22.027 – Managing monitoring visits and subsequent reports
- Author Name: Karen Montgomery
- Version: 4.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- Form 22.027A – Monitoring Visit Log (Pharmacy)
SOP 22.028 – Labelling of IMPs and NIMPs in Clinical Trials that are hosted by NHSGGC
- Author Name: Maria Nygren
- Version: 5.0
- Active Date: 21/06/2024
- Review Date: 31/12/2027
Associated Documents
- Guideline 22.028A – Labelling of IMPs and NIMPs in Clinical Trials Hosted by NHSGGC
SOP 22.030 – Role of NHSGGC Pharmacy Clinical Trial Services: an overview
- Author Name: Kirsty McLeish
- Version: 4.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.031 – Role of pharmacy services in support of trials that are hosted by NHSGGC: an overview
- Author Name: Kirsty McLeish
- Version: 4.0
- Active Date: 28/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.033 – Incident reporting for pharmacy clinical trials
- Author Name: Maria Nygren
- Version: 4.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.034 – Management of controlled drug IMPs within pharmacy sites
- Author Name: Kirsty McLeish
- Version: 3.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.035 – Clinical trial information provided to site on-call pharmacists
- Author Name: Ramis Qureshi
- Version: 3.0
- Active Date: 21/06/2024
- Review Date: 31/12/2027
Associated Documents
- Form 22.035A – Clinical Trial Information Provided to Site On-Call Pharmacists
SOP 22.037 – Tracking and Release of IMPs placed into quarantine post delivery at pharmacy sites
- Author Name: Linda Taylor
- Version: 3.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.038 – Introduction To Genetically Modified Organism (GMO) Products Within Clinical Trials
- Author Name: Martin Ball
- Version: 2.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- Guideline 22.038A – Introduction to Genetically Modified Product (GMO) in Clinical Trials
SOP 22.039 – Cleaning The Aseptic Room And Isolator Used To Prepare Genetically Modified Organism Products (GMO)
- Author Name: Martin Ball
- Version: 2.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.040 – Safe Handling Of Spillage, Personal Contamination or Injury Involving Genetically Modified Organism (GMO) Products
- Author Name: Martin Ball
- Version: 2.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.041 – Aseptic Preparation of Genetically Modified Organism (GMO) Products
- Author Name: Martin Ball
- Version: 2.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.042 – Personal Protective Equipment (PPE) To Be Worn When Handling Genetically Modified Organism (GMO) Products
- Author Name: Martin Ball
- Version: 2.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.043 – Environmental Monitoring Of The Isolator And Room Used To Prepare Genetically Modified Organism (GMO) Products
- Author Name: Martin Ball
- Version: 2.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.044 – Transportation Of Genetically Modified Organism (GMO) Products
- Author Name: Martin Ball
- Version: 2.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.045 – Safe Handling Of Genetically Modified Organism (GMO) Products Waste
- Author Name: Martin Ball
- Version: 2.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.046 – Remote Provision of Professional Check of Clinical Trial Prescriptions
- Author Name: Jennifer McAughtrie
- Version: 2.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.047 – Processing of clinical trial prescriptions scanned to pharmacy
- Author Name: Ramis Qureshi
- Version: 2.0
- Active Date: 21/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.048 – Pharmacy authorisation process for studies involving Advanced Therapy Investigational Medicinal Products (ATIMPs)
- Author Name: Martin Ball
- Version: 2.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.049 – Pharmacy process for receipt and transfer of Advanced Therapy Investigational Medicinal Products (ATIMPs)
- Author Name: Martin Ball
- Version: 2.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 22.050 – Recording Pharmacy Clinical Trial Activity for Income Generation
- Author Name: Angela Carruth
- Version: 2.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- Guideline 22.050A – EDGE Pharmacy Work Instruction
Chapter 23 – NHS GG&C Pharmacy – Hosted Non-CTIMPs
SOP 23.001 – Role of Pharmacy Services in Support of Other Clinical Research within NHSGGC: an Overview
- Author Name: Kirsty McLeish
- Version: 3.0
- Active Date: 28/06/2024
- Review Date: 31/12/2027
Associated Documents
- None
Chapter 50 – NHS GG&C General
SOP 50.009 – Project Numbering
- Author Name: Kirsty Theron
- Version: 5.0
- Active Date: 03/09/2023
- Review Date: 31/12/2026
Associated Documents
- Form 50.009A – Project ID Log
SOP 50.010 – Project Data Entry on SReDA
- Author Name: Radek Penar
- Version: 7.0
- Active Date: 22/04/2025
- Review Date: 31/12/2028
Associated Documents
- Form 50.010B – Confirmation of Grant Status
SOP 50.011 – Setting up and Maintaining Research and Innovation project files (for R&I office approvals)
- Author Name: Kirsty Theron
- Version: 5.0
- Active Date: 09/06/2023
- Review Date: 31/12/2026
Associated Documents
- Form 50.011A – E-Folder Index
- Form 50.011B – Innovation Projects E-Folder Index
SOP 50.013 – Setup and maintenance of training files: NHS
- Author Name: Nicola Thomson
- Version: 5.0
- Active Date: 04/03/2025
- Review Date: 31/12/2028
Associated Documents
- Form 50.013A – NHS Training Folder File Note
- Form 50.013E – Training Record
- Form 50.013F – Training File Index
SOP 50.016 – Development of new processes within NHS GG&C R&I
- Author Name: Paul Gribbon
- Version: 4.0
- Active Date: 31/03/2022
- Review Date: 31/12/2025
Associated Documents
- Form 50.016A – Process Development Plan
- Form 50.016B – Process Development Plan Appraisal
SOP 50.017 – Research & Innovation Document Management
- Author Name: Paul Gribbon
- Version: 5.0
- Active Date: 14/05/2025
- Review Date: 31/12/2028
Associated Documents
- None
SOP 50.019 – Independent Stakeholder Assessment
- Author Name: Paul Gribbon
- Version: 2.0
- Active Date: 06/09/2023
- Review Date: 31/12/2026
Associated Documents
- Form 50.019A – Independent Stakeholder Assessment Form
- Guideline 50.019A – Independent Stakeholder Assessment Guidance
SOP 50.020 – eCRF User Acceptance Testing (Glasgow Clinical Trials Unit)
- Author Name: Paul Gribbon
- Version: 2.0
- Active Date: 20/12/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 50.021 – Participant recruitment sourcing and recording
- Author Name: Radek Penar
- Version: 2.0
- Active Date: 08/05/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 50.022 – Preparation and Maintenance of Terms of Reference
- Author Name: Paul Gribbon
- Version: 2.0
- Active Date: 20/12/2023
- Review Date: 31/12/2026
Associated Documents
- Form 50.022A – Terms of Reference Template
SOP 50.023 – Management of SOPs within NHS GG&C R&I
- Author Name: Paul Gribbon
- Version: 1.0
- Active Date: 25/08/2022
- Review Date: 31/12/2025
Associated Documents
- Form 50.023A – RACI Matrix for R&I SOPs
- Guideline 50.023A – Management of SOPs through Q-Pulse Guide
SOP 50.024 – Management of the Central Portfolio Management System
- Author Name: Radek Penar
- Version: 1.0
- Active Date: 29/08/2023
- Review Date: 31/12/2026
Associated Documents
- Form 50.024A – CPMS Minimum Dataset
SOP 50.025 – Quality Check of Project Entries on SReDA
- Author Name: Radek Penar
- Version: 1.0
- Active Date: 05/03/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 50.026 – Internal QC checks of Scottish Research Database Application (SReDA)
- Author Name: Radek Penar
- Version: 4.0
- Active Date: 05/03/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 50.027 – Service Level and Operational Level Agreements
- Author Name: Paul Gribbon
- Version: 1.0
- Active Date: 25/10/2024
- Review Date: 31/12/2027
Associated Documents
- None
Chapter 51 – NHS GG&C Sponsor R&I
SOP 51.001 – Protocol Development
- Author Name: Louise Ner
- Version: 6.0
- Active Date: 02/11/2022
- Review Date: 31/12/2025
Associated Documents
- None
SOP 51.002 – Participant Information Sheet and Consent Forms: Design and Approval
- Author Name: Louise Ner
- Version: 6.0
- Active Date: 30/06/2025
- Review Date: 31/12/2028
Associated Documents
- Guideline 51.002A – Participant Information Sheet and Informed Consent Form Guidelines
SOP 51.003 – Peer review
- Author Name: Maureen Travers
- Version: 4.0
- Active Date: 02/11/2022
- Review Date: 31/12/2025
Associated Documents
- Form 51.003A – PROGRAMME ASSESSMENT REVIEW FORM
SOP 51.004 – Risk Assessment
- Author Name: Maureen Travers
- Version: 5.0
- Active Date: 18/01/2022
- Review Date: 31/12/2025
Associated Documents
- Form 51.004A – Risk Assessment tool
- Form 51.004B – Research Study Risk Assessment
- Form 51.004C – Hosted Non-Commercial CTIMP Risk Assessment
- Guideline 51.004A – Clinical Trial Risk Assessment Guidance Document
SOP 51.005 – R&I – End of study procedures
- Author Name: Shanice White
- Version: 4.0
- Active Date: 03/09/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 51.007 – Identifying a Sponsor organisation
- Author Name: Louise Ner
- Version: 6.0
- Active Date: 01/09/2025
- Review Date: 31/12/2028
Associated Documents
- Form 51.007A – International Site Questionnaire
- Form 51.007B – NHSGGC and University of Glasgow Co-Sponsor Letter
- Form 51.007C – NHSGGC Sponsor Letter
- Form 51.007D – Responsibilities delegated to the Chief Investigator for CTIMP Trials Co-Sponsored by the University of Glasgow and NHS GG&C
- Form 51.007E – Responsibilities delegated to the Chief Investigator for CTIMP Trials Sponsored by NHS GG&C
SOP 51.008 – Handling non-compliance with Good Clinical Practice (GCP) and/or the trial protocol in clinical research sponsored, co-sponsored or hosted by NHS Greater Glasgow and Clyde
- Author Name: Caroline Watson
- Version: 4.0
- Active Date: 19/04/2022
- Review Date: 31/12/2025
Associated Documents
- Form 51.008A – Protocol Deviation Reporting Form
- Form 51.008B – Protocol Deviation Reporting Form (Part 2)
- Form 51.008C – Protocol Deviation Log
- Guideline 51.008A – Non-Compliance Q-Pulse Guide
- Guideline 51.008B – PROTOCOL DEVIATION GUIDANCE
SOP 51.009 – Notification of Serious Breaches of Good Clinical Practice or the Trial Protocol for Clinical Trials of Investigational Medicinal Products and non-CA marked Medical Devices
- Author Name: Caroline Watson
- Version: 5.0
- Active Date: 25/11/2024
- Review Date: 31/12/2027
Associated Documents
- Form 51.009A – Record of Breach Assessment Group
SOP 51.010 – Preparation and Review of Grant Applications and Costs
- Author Name: Heather Flanagan
- Version: 5.0
- Active Date: 24/07/2023
- Review Date: 31/12/2026
Associated Documents
- Form 51.010A – NHS Project Costs for Non-commercial Research
- Form 51.010D – Grant with potential non CA/CE marked medical device – Checklist
- Form 51.010E – R&I Study Strategic Plan
- Guideline 51.010A – Guidelines for identifying category of research funding organisation
SOP 51.011 – University of Glasgow and NHS Greater Glasgow and Clyde Co-Sponsorship Agreement
- Author Name: Maureen Travers
- Version: 4.0
- Active Date: 10/04/2021
- Review Date: 31/12/2024
Associated Documents
- Form 51.011A – Short Letter CTA CI Employer
- Form 51.011C – Proforma for signing of Non-Commercial Funded Clinical trial Agreement
SOP 51.014 – Preparation and submission of IRAS forms
- Author Name: Maureen Travers
- Version: 4.0
- Active Date: 02/11/2022
- Review Date: 31/12/2025
Associated Documents
- None
SOP 51.015 – Assessment of Vendors
- Author Name: Paul Gribbon
- Version: 5.0
- Active Date: 10/04/2024
- Review Date: 31/12/2027
Associated Documents
- Form 51.015B – Data Management Vendor Assessment
- Form 51.015C – Laboratory Vendor Assessment
- Form 51.015D – IMP Manufacturer Vendor Assessment Form
- Form 51.015E – NHS GG&C Vendor Assessment Tool For IMP Manufactures
- Form 51.015H – Collaborator Assessment Questionnaire
- Form 51.015I – Vendor Exemption Letter
- Form 51.015L – Imaging Facility Vendor Assessment
- Guideline 51.015A – IMP Manufacturer Vendor Assessment Process
- Guideline 51.015B – Use of Q-Pulse for Vendor Assessment Guide
SOP 51.016 – Preparation and Maintenance of a Trial Master File
- Author Name: Liz Anne Lewsley
- Version: 6.0
- Active Date: 05/08/2025
- Review Date: 31/12/2028
Associated Documents
- Form 51.016A – Sponsor TMF Index
- Form 51.016C – Investigator Site File:Template
- Form 51.016J – TMF Cover Sheet
- Form 51.016K – TMF Index Pages
- Form 51.016L – Vendor TMF Plan Template
- Form 51.016M – TMF/ISF File Note
- Guideline 51.016A – Quality Control of Trial Master File
- Guideline 51.016B – Sponsor TMF Index Guidelines
SOP 51.017 – Registration of research projects on public databases
- Author Name: Heather Flanagan
- Version: 4.0
- Active Date: 26/07/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 51.019 – Sponsor End of study procedures
- Author Name: Shanice White
- Version: 4.0
- Active Date: 22/04/2025
- Review Date: 31/12/2028
Associated Documents
- Form 51.019A – Project Status E-Mail Template
- Form 51.019B – MHRA Cover Letter
SOP 51.020 – Sponsor Regulatory Green Light
- Author Name: Liz Anne Lewsley
- Version: 4.0
- Active Date: 29/04/2024
- Review Date: 31/12/2027
Associated Documents
- Form 51.020A – Sponsor CTIMP Regulatory Green Light Letter
- Form 51.020B – Sponsor Oversight Checklist For Issuing RGL
SOP 51.021 – Review and Approval of Amendments for Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
- Author Name: Louise Ner
- Version: 5.0
- Active Date: 10/04/2024
- Review Date: 31/12/2027
Associated Documents
- Form 51.021A – Amendment Type Confirmation Email
- Form 51.021B – Amendment Log
- Form 51.021C – Sponsor Review of Amendment Checklist
- Form 51.021D – Management Approval is still valid – email template
SOP 51.022 – Research & Innovation Data & Administration tasks
- Author Name: Shanice White
- Version: 4.0
- Active Date: 29/08/2023
- Review Date: 31/12/2026
Associated Documents
- Guideline 51.022A – SReDA End Date Process
SOP 51.023 – Sponsor process for an IDMC
- Author Name: Liz Anne Lewsley
- Version: 5.0
- Active Date: 25/08/2022
- Review Date: 31/12/2025
Associated Documents
- Form 51.023A – Template IDMC Charter
- Form 51.023B – IDMC recommendation form
- Form 51.023C – Letter of Invitation to IDMC member GG&C sole Sponsor
- Form 51.023D – Letter of Invitation to IDMC member GG&C/UoG co-sponsor
SOP 51.024 – Archiving Essential Documents from Clinical Research Process for a GGC Sponsored/Co Sponsored CTIMP and/or CIMD
- Author Name: Heather Flanagan
- Version: 2.0
- Active Date: 20/12/2023
- Review Date: 31/12/2026
Associated Documents
- Form 51.024A – Essential Documents for Archiving Archiving Checklist (for CTIMPs)
- Form 51.024E – Trial Archiving Oversight
SOP 51.025 – Archiving Essential Documents from Clinical Research Process for a Sponsored Non CTIMP
- Author Name: Maureen Travers
- Version: 1.0
- Active Date: 04/12/2018
- Review Date: 31/12/2023
Associated Documents
- Form 51.025A – Essential Documents for Archiving – Archiving Checklist (for Non-CTIMPs)
SOP 51.028 – NHS Laboratory samples for Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow or hosted by NHSGGC.
- Author Name: Lynsey Gillespie
- Version: 5.0
- Active Date: 05/03/2024
- Review Date: 31/12/2027
Associated Documents
- Form 51.028A – Categorising Laboratory Tests undertaken within Research Projects Sponsored by NHS GG&C or Co-Sponsored by NHS GG&C and University of Glasgow
SOP 51.029 – Writing Study Specific Laboratory Manuals for Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
- Author Name: Lynsey Gillespie
- Version: 4.0
- Active Date: 05/03/2024
- Review Date: 31/12/2027
Associated Documents
- Form 51.029A – Laboratory Manual
SOP 51.030 – Writing Sample Handling Manuals for Sites Participating in Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
- Author Name: Lynsey Gillespie
- Version: 3.0
- Active Date: 25/01/2024
- Review Date: 31/12/2027
Associated Documents
- Form 51.030A – Site Sample Log
- Form 51.030B – Sample Transfer Form
- Form 51.030C – Sample Handling Manual
SOP 51.031 – Corrective and Preventative Action Plan Management
- Author Name: Paul Gribbon
- Version: 2.0
- Active Date: 06/09/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 51.033 – Research Imaging for Trials involving an Investigative Medicinal Compound (CTIMP) Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and the University of Glasgow (UoG)
- Author Name: Tracey Hopkins
- Version: 1.0
- Active Date: 03/09/2020
- Review Date: 31/12/2023
Associated Documents
- Form 51.033A – Categorising Imaging Tests undertaken within CTIMPS Sponsored by NHS GG&C or Co-Sponsored by NHS GG&C and University of Glasgow
- Form 51.033B – MRI Site Survey Template
- Form 51.033C – CT Site Survey Template
SOP 51.034 – Writing a Trial Specific Research Imaging Manual for Sites Participating in CTIMP Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and University of Glasgow (UoG)
- Author Name: Tracey Hopkins
- Version: 1.0
- Active Date: 03/09/2020
- Review Date: 31/12/2023
Associated Documents
- Form 51.034A – Sponsor Imaging Manual Template
- Form 51.034B – CT/MRI Subject Data Transmittal Form Template
- Form 51.034C – Template MRI/CT Protocol
- Form 51.034D – CT/MRI Imaging Parameters Template
- Form 51.034E – Data Transfer Log
SOP 51.035 – Design and Development of CRFs/eCRFs in CTIMPs and Clinical Investigations
- Author Name: Marc Jones
- Version: 1.0
- Active Date: 02/11/2022
- Review Date: 31/12/2025
Associated Documents
- None
SOP 51.036 – Trial Steering Committee for Trials involving an Investigative Medicinal Compound (CTIMP) Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and the University of Glasgow
- Author Name: Heather Flanagan
- Version: 2.0
- Active Date: 25/08/2022
- Review Date: 31/12/2025
Associated Documents
- Form 51.036A – Letter of Invitation to TSC member GG&C sole Sponsor
- Form 51.036B – Letter of Invitation to TSC member GG&C/UoG co-sponsor
SOP 51.037 – Storage and Transfer of Laboratory Data for Clinical Trials and Investigations Sponsored by NHS Greater Glasgow & Clyde (NHS GG&C) or Co-Sponsored by NHS GG&C & University of Glasgow
- Author Name: Marc Jones
- Version: 1.0
- Active Date: 03/03/2022
- Review Date: 31/12/2025
Associated Documents
- None
Chapter 52 – NHS GG&C Hosted R&I
SOP 52.001 – Obtaining NHS Management Approval Non-commercial
- Author Name: Karen Chase
- Version: 4.0
- Active Date: 27/06/2025
- Review Date: 31/12/2028
Associated Documents
- Form 52.001A – Non-Commercial Finance Template
- Form 52.001B – OID Appendix
- Form 52.001C – Management Approval Letter
SOP 52.002 – Obtaining NHS Management Approval for Commercial Studies
- Author Name: Ross Nicol
- Version: 4.0
- Active Date: 09/06/2023
- Review Date: 31/12/2026
Associated Documents
- Form 52.002C – Commercial Permission Letter
SOP 52.003 – R&I Review of Amendments
- Author Name: Ruth Pink
- Version: 5.0
- Active Date: 25/08/2022
- Review Date: 31/12/2025
Associated Documents
- Form 52.003A – R&D Amendment Checklist
- Form 52.003B – Amendment Approval Email Category A or B
- Form 52.003C – Amendment Approval/Acknowledgement Emails – Substantial Amendment
- Form 52.003D – Amendment Approval/Acknowledgement Emails – Substantial Amendment & Protocol Amendment
- Form 52.003E – Amendment Acknowledgement
- Guideline 52.003A – Pharmacy Clinical Trials Amendment Approval Guidance
- Guideline 52.003B – Flowchart for processing amendments
SOP 52.004 – R&I Contract Development and Review
- Author Name: Ross Nicol
- Version: 5.0
- Active Date: 03/09/2023
- Review Date: 31/12/2026
Associated Documents
- Form 52.004A – Contract Review Checklist
SOP 52.005 – Review of Research Passport and issuing of Honorary Research Contracts/Letters of Access
- Author Name: Rozanne Suarez
- Version: 5.0
- Active Date: 08/05/2024
- Review Date: 31/12/2027
Associated Documents
- Form 52.005A – Letter Template – Honorary Research Contract
- Form 52.005B – Letter Template – Letter of Access
- Form 52.005C – Letter Template – Letter of Access (Staff Studies Only)
- Form 52.005D – Letter Template – Letter of Access (NHS to NHS)
SOP 52.007 – Authorisations for NHS resource use in R&D submissions
- Author Name: Karen Chase
- Version: 3.0
- Active Date: 18/03/2020
- Review Date: 31/12/2023
Associated Documents
- Form 52.007A – Imaging Research – Research Trial Imaging Details
- Form 52.007B – Sample email of notification to Head of Clinical Department or Clinical Service Manager
SOP 52.009 – Validation of Project Submissions for R&I Management Approval: NHS
- Author Name: Shanice White
- Version: 4.0
- Active Date: 09/06/2023
- Review Date: 31/12/2026
Associated Documents
- Form 52.009A – Checklist of documents required for R&I submission
- Form 52.009B – Template email to investigator
- Form 52.009C – Template e-file
- Form 52.009D – Project File checklist
SOP 52.013 – Process for approving studies and trials involving a Genetically Modified Organism (GMO)
- Author Name: Caroline Watson
- Version: 2.0
- Active Date: 28/09/2023
- Review Date: 31/12/2026
Associated Documents
- Form 52.013A – GMO Contained Use Regulations
- Form 52.013B – GMO Deliberate Release
- Form 52.013C – GMO Trials
SOP 52.014 – Archiving Essential Documents from Clinical Research Process for Hosted Research
- Author Name: Radek Penar
- Version: 2.0
- Active Date: 06/10/2025
- Review Date: 31/12/2028
Associated Documents
- Form 52.014A – Archiving Certificate
SOP 52.015 – Phase I First in Human Committee Review Process
- Author Name: Emma Whitelaw
- Version: 2.0
- Active Date: 20/12/2023
- Review Date: 31/12/2026
Associated Documents
- Form 52.015A – Categorisation of Phase I (FIH) Trial
- Form 52.015B – Phase I Risk Assessment
- Form 52.015C – Phase I and High Risk Reviewers comments
- Form 52.015D – Phase I or High Risk Committees Combined Review
Chapter 53 – NHS GG&C Sponsor Governance
SOP 53.001 – Handling Urgent Safety Measures for Clinical Trials for Investigational Medicinal Products and non-CA marked Medical Devices
- Author Name: Caroline Watson
- Version: 4.0
- Active Date: 10/04/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 53.002 – The Handling of Poor Quality and Fraud in Clinical Research
- Author Name: Caroline Watson
- Version: 4.0
- Active Date: 07/05/2022
- Review Date: 31/12/2028
Associated Documents
- Form 53.002A – Reporting of fraud in clinical trials of an investigational medicinal product not identified as a serious breach of GCP
SOP 53.003 – Temporary halt or early termination of clinical trials of investigational medicinal products
- Author Name: Caroline Watson
- Version: 4.0
- Active Date: 25/01/2024
- Review Date: 31/12/2027
Associated Documents
- None
SOP 53.004 – Monitoring Clinical Research – Site Monitoring Visit
- Author Name: Sheila Mcgowan
- Version: 7.0
- Active Date: 29/10/2024
- Review Date: 31/12/2027
Associated Documents
- Form 53.004E – Telephone Contact Form
- Form 53.004F – Monitoring Visit Agenda Template
- Form 53.004G – Monitoring Visit Log
- Form 53.004H – Preliminary Follow Up letter / Follow Up letter
- Form 53.004P – Clinical Trial Monitor Remote Monitoring Agreement
- Guideline 53.004A – Q-Pulse Guidance for Monitoring Visit
SOP 53.005 – GCP Audit of Research studies and systems supporting research
- Author Name: Paul Gribbon
- Version: 7.0
- Active Date: 18/02/2022
- Review Date: 31/12/2025
Associated Documents
- Form 53.005A – Research Audit Plan
- Form 53.005C – Research Study Site File Index
- Form 53.005D – Responsibilities Log
- Form 53.005E – Screening/Recruitment/Withdrawal Log
- Form 53.005F – Patient Identification Log
- Form 53.005G – Key Study Contacts
- Form 53.005H – Site Tracker/Protocol/Amendment Distribution Log
- Form 53.005I – Training Log
- Form 53.005K – Archiving Log
- Form 53.005N – Participating Site File Index
- Form 53.005P – Internal Audit Schedule
- Form 53.005Q – Audit Start Up Communication Letter
- Form 53.005R – Remote Trial Health Check Generator
- Form 53.005S – Remote Audit Start Up Communication Letter
- Form 53.005T – Internal Audit – Approved Auditors
- Form 53.005U – Audit Finding Reminder
- Form 53.005V – Audit Reminder
- Form 53.005W – Perceived Risk Feedback
- Form 53.005X – Audit Report Template
SOP 53.006 – Monitoring Handover Checklist Process
- Author Name: Sheila Mcgowan
- Version: 2.0
- Active Date: 25/08/2022
- Review Date: 31/12/2025
Associated Documents
- Form 53.006A – Research & Innovation Monitoring Handover Checklist
SOP 53.007 – Unblinded Monitoring Process
- Author Name: Sheila Mcgowan
- Version: 2.0
- Active Date: 12/06/2022
- Review Date: 31/12/2025
Associated Documents
- None
SOP 53.008 – Accompanied and Training Visit Process
- Author Name: Sheila Mcgowan
- Version: 2.0
- Active Date: 03/09/2023
- Review Date: 31/12/2026
Associated Documents
- Form 53.008A – Accompanied Visit Checklist
SOP 53.009 – Preparation and Maintenance of a Clinical Trial Monitoring File
- Author Name: Sheila Mcgowan
- Version: 2.0
- Active Date: 25/08/2022
- Review Date: 31/12/2025
Associated Documents
- None
SOP 53.010 – Monitoring Clinical Research Preparation and Management of a Monitoring Plan
- Author Name: Emma Moody
- Version: 2.0
- Active Date: 18/06/2024
- Review Date: 31/12/2027
Associated Documents
- Form 53.010A – Monitoring Plan for a Clinical Trial of an Investigational Medicinal Product/Medical Device Investigation
- Form 53.010B – NHSGGC Monitoring Risk Assessment
- Form 53.010C – Research & Innovation Monitoring Plan Tracking Log
SOP 53.011 – Sponsor Source Data Requirements and Guidance
- Author Name: Sheila Mcgowan
- Version: 2.0
- Active Date: 01/08/2025
- Review Date: 31/12/2028
Associated Documents
- None
SOP 53.012 – Monitoring Clinical Research Site Close Out Monitoring visit
- Author Name: Emma Moody
- Version: 1.0
- Active Date: 25/08/2022
- Review Date: 31/12/2025
Associated Documents
- None
SOP 53.013 – Monitoring Clinical Research For Cause Monitoring Visit
- Author Name: Emma Moody
- Version: 1.0
- Active Date: 25/08/2022
- Review Date: 31/12/2025
Associated Documents
- None
SOP 53.014 – External Sponsor Monitoring Arrangement
- Author Name: Sheila Mcgowan
- Version: 1.0
- Active Date: 29/04/2024
- Review Date: 31/12/2027
Associated Documents
- Form 53.014A – External Sponsor Monitoring Process Arrangement
SOP 53.015 – Monitoring Clinical Research – Site Compliance Visit
- Author Name: Sheila Mcgowan
- Version: 1.0
- Active Date: 29/10/2024
- Review Date: 31/12/2027
Associated Documents
- None
Chapter 55 – NHS GG&C Pharmacovigilance
SOP 55.001 – Pharmacovigilance in Clinical Trials of Investigational Medicinal Products (Glasgow Clinical Trials Unit)
- Author Name: Marc Jones
- Version: 8.0
- Active Date: 06/09/2023
- Review Date: 31/12/2026
Associated Documents
- Form 55.001A – Sponsor Safety Reporting Plan
- Guideline 55.001A – PV Office Preparation of Sponsor Safety Reporting Plan, Glasgow Clinical Trials Unit (GCTU) Pharmacovigilance (PV) Office
- Guideline 55.001B – PV Office Expediting SUSARs
- Guideline 55.001C – PV Office Submitting SUSAR reports to MHRA via ICSR
- Guideline 55.001F – PV Office Pharmacovigilance File
- Guideline 55.001G – PV Office Processing for Clinical Trials of Investigational Medicinal Products
SOP 55.002 – Preparation and Submission of the Development Safety Update Report
- Author Name: Marc Jones
- Version: 5.0
- Active Date: 10/09/2019
- Review Date: 31/12/2026
Associated Documents
- Form 55.002A – Development Safety Update Report (DSUR) Template
- Form 55.002B – DSUR Investigator Checklist
- Guideline 55.002A – PV Office Creation and submission of Development Safety Update Reports
SOP 55.004 – Safety RepSafety Reporting Requirements for Research Other Than Clinical Trials of Investigational Medicinal Products and non CE Marked Medical Devices
- Author Name: Marc Jones
- Version: 5.0
- Active Date: 06/09/2023
- Review Date: 31/12/2026
Associated Documents
- Guideline 55.004A – Completion Guidelines: Generic Non-CTIMP Serious Adverse Event Form
- Guideline 55.004B – PV Office Processing for Non-CTIMP Studies
SOP 55.005 – Initial Review and Management of Updates to Reference Safety Information
- Author Name: Marc Jones
- Version: 5.0
- Active Date: 18/11/2021
- Review Date: 31/12/2027
Associated Documents
- Form 55.005A – Reference Safety Information Front Sheet
- Form 55.005B – RSI Summary
- Guideline 55.005A – PV Office Handling Drug Alerts
SOP 55.006 – Selection and Periodic Review of IBs and SmPCs in CTIMPs for Clinical Management
- Author Name: Marc Jones
- Version: 5.0
- Active Date: 18/11/2021
- Review Date: 31/12/2027
Associated Documents
- Form 55.006A – SmPC Tracker for Sponsored/Co-Sponsored Clinical Trials
- Form 55.006B – IB Tracker for Sponsored/Co-Sponsored Clinical Trials
- Form 55.006C – SmPC Update Monitor Form
- Guideline 55.006A – Summary of Product Characteristics (SmPC) & Investigator s Brochure Checks
SOP 55.007 – Safety Reporting in Clinical Trials of Medical Devices of Non CE Marked Medical Devices or CE Marked Devices Used Outside of their Intended Purpose (Sponsored and Hosted Clinical Investigations)
- Author Name: Marc Jones
- Version: 2.0
- Active Date: 19/07/2018
- Review Date: 31/12/2025
Associated Documents
- Guideline 55.007A – PV Office Processing for Clinical Investigations of Non CE Marked medical Devices
SOP 55.015 – Sponsor Pharmacovigilance Data
- Author Name: Marc Jones
- Version: 4.0
- Active Date: 06/07/2024
- Review Date: 31/12/2027
Associated Documents
- Form 55.015A – SAE Processing Form
SOP 55.016 – Sponsor IB Assessment
- Author Name: Paula Morrison
- Version: 1.0
- Active Date: 05/09/2022
- Review Date: 31/12/2025
Associated Documents
- None
SOP 55.017 – Sponsor Quality Control of SAEs Processed by the Pharmacovigilance Office
- Author Name: Marc Jones
- Version: 2.0
- Active Date: 26/02/2025
- Review Date: 31/12/2028
Associated Documents
- Form 55.017A – SAE QC Review Log
Chapter 56 – NHS GG&C Sponsor Project Management Unit
SOP 56.001 – Site Set up – Green for Go Process
- Author Name: Lynsey Gillespie
- Version: 8.0
- Active Date: 22/05/2024
- Review Date: 31/12/2027
Associated Documents
- Form 56.001B – Green For Go Checklist
- Form 56.001C – IMP Release Email Template
- Form 56.001D – Green for Go Email Template
- Form 56.001E – Protocol Approval/Signature Page
- Form 56.001G – LIP Email Template
- Form 56.001H – Principal Investigator Site File Index (non-CTIMP): Template
SOP 56.002 – Project Management Trial Set-up
- Author Name: Lynsey Gillespie
- Version: 5.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- Form 56.002B – Status Update
- Form 56.002C – Screening Log
- Form 56.002D – Site Delegation Log
- Form 56.002E – Communication Plan
- Form 56.002F – Clinical Trial Protocol Training Log
- Form 56.002G – Enrolment & Patient ID Log
- Form 56.002L – Laboratory Master Research File
- Form 56.002M – Source Data Plan
- Form 56.002O – Trial Management Group Meeting Agenda
SOP 56.003 – Project Management: Managing an Active Trial
- Author Name: Lynsey Gillespie
- Version: 5.0
- Active Date: 28/06/2024
- Review Date: 31/12/2027
Associated Documents
- Form 56.003A – Sponsor Oversight Committee Escalation
- Form 56.003B – Amendment Tracker
- Form 56.003C – Change Proposal Form Change Control Log
- Form 56.003D – Amendment Email Template
- Guideline 56.003A – Escalation process for actions impacting project delivery and study integrity
SOP 56.004 – Project Management Trial Site Close-Out
- Author Name: Lynsey Gillespie
- Version: 3.0
- Active Date: 21/08/2023
- Review Date: 31/12/2026
Associated Documents
- Form 56.004A – Site Study Close Out Checklist
- Form 56.004B – Site Close Out Confirmation
SOP 56.007 – Project Management Site Capability Assessment
- Author Name: Lynsey Gillespie
- Version: 2.0
- Active Date: 18/08/2023
- Review Date: 31/12/2026
Associated Documents
- Form 56.007A – Site Capability Assessment
Chapter 57 – NHS GG&C Clinical Research Facility – Administration
SOP 57.001 – Managing a Monitoring Visit
- Author Name: Helen Hart
- Version: 9.0
- Active Date: 28/09/2022
- Review Date: 31/12/2025
Associated Documents
- Form 57.001B – Clinical Portal External User
- Form 57.001C – Clinical Visit with Study Staff External to NHS GG&C Checklist
- Form 57.001D – Consent Form for Observed Clinical Visit
- Form 57.001E – Informed Consent Quality Check
- Guideline 57.001A – Clinical Portal Access for External Users in GCRF
- Guideline 57.001B – Creating and sharing a worklist on Clinical Portal
- Guideline 57.001C – Remote Monitoring Visit
SOP 57.002 – Management of paper health records
- Author Name: Kate Smith
- Version: 4.0
- Active Date: 23/06/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 57.003 – GCRF Internal Audit
- Author Name: Helen Hart
- Version: 4.0
- Active Date: 10/10/2023
- Review Date: 31/12/2026
Associated Documents
- Form 57.003A – Internal Audit Schedule
- Form 57.003B – Internal Audit Plan
- Form 57.003C – Internal Audit Report
- Form 57.003D – Non-compliance and CAPA Report
- Guideline 57.003A – GCRF Non-compliance and CAPA Report
SOP 57.004 – GCRF Booking, Admission and Discharge of Research Participants
- Author Name: Kate Smith
- Version: 3.0
- Active Date: 23/06/2023
- Review Date: 31/12/2026
Associated Documents
- Form 57.004A – GCRF Room Booking Request
- Form 57.004C – Reception Checklist
- Form 57.004D – General Admin Tasks
- Guideline 57.004A – Glasgow Clinical Research Facility Reception Duties
- Guideline 57.004B – GCRF Room Booking
SOP 57.005 – GCRF Hosted Study Documentation and Data Management
- Author Name: Helen Hart
- Version: 4.0
- Active Date: 08/03/2023
- Review Date: 31/12/2026
Associated Documents
- Form 57.005A – GCRF Archive Box Contents
- Guideline 57.005A – GCRF Data Transfer
- Guideline 57.005B – GCRF Archiving Process
- Guideline 57.005C – Redaction Process
SOP 57.006 – GCRF Principal Investigator Responsibilities
- Author Name: Helen Hart
- Version: 3.0
- Active Date: 28/09/2022
- Review Date: 31/12/2025
Associated Documents
- Guideline 57.006A – PI Oversight Plan
SOP 57.007 – GCRF Communications
- Author Name: Helen Hart
- Version: 5.0
- Active Date: 25/03/2025
- Review Date: 31/12/2028
Associated Documents
- Form 57.007A – GCRF Agenda Template
- Form 57.007B – GCRF Meeting Summary Template
- Form 57.007C – GCRF PowerPoint Template
- Form 57.007D – GCRF PPI Confidentiality Agreement
- Form 57.007E – GCRF Social Media Template
- Form 57.007F – GCRF Staff Media Consent
- Form 57.007G – GCRF TEAMS Background
- Guideline 57.007A – GCRF Team Huddle Guidance and Summary
- Guideline 57.007B – GCRF Social Media Guidance and Summary
SOP 57.008 – External Audit and Inspection
- Author Name: Helen Hart
- Version: 3.0
- Active Date: 17/11/2023
- Review Date: 31/12/2026
Associated Documents
- Form 57.008A – External Audit/Inspection Notification Checklist
- Form 57.008B – External Audit/Inspection Document Request
- Form 57.008C – External Audit/Inspection Scribe Template
- Form 57.008D – External Audit/Inspection Document Tracker
- Form 57.008E – External Audit/Inspection CAPA Tracker
SOP 57.010 – Study Planning, Set-up and Start-up
- Author Name: Helen Hart
- Version: 4.0
- Active Date: 13/05/2024
- Review Date: 31/12/2027
Associated Documents
- Form 57.010A – GCRF Study Support
- Form 57.010B – GCRF Site Initiation Visit Checklist
- Form 57.010C – GCRF Capacity Confirmation
- Form 57.010D – GCRF PI Support Letter
- Form 57.010E – Study Eligibility Source Worksheet Template
- Form 57.010F – Study Visit Source Worksheet Template
- Guideline 57.010B – Planning meeting
- Guideline 57.010C – GCRF Site Capability
- Guideline 57.010D – Local Information Pack (LIP) Submission
- Guideline 57.010E – Localising Participant Facing Documents
- Guideline 57.010F – Out-of-hours Switchboard Contact
- Guideline 57.010G – Source data worksheets
- Guideline 57.010H – GCRF New PI Process
SOP 57.011 – GCRF Study Management
- Author Name: Helen Hart
- Version: 3.0
- Active Date: 24/11/2023
- Review Date: 31/12/2026
Associated Documents
- Form 57.011A – Study Handover
- Form 57.011B – Amendment Tracker
- Form 57.011C – Protocol Deviation Log
- Guideline 57.011A – Investigator Site File (ISF)
- Guideline 57.011B – Study Amendments
SOP 57.012 – GCRF Security and Access
- Author Name: Kate Smith
- Version: 3.0
- Active Date: 23/06/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 57.014 – GCRF Support of Early Phase Clinical Trials
- Author Name: Patricia Clark
- Version: 1.0
- Active Date: 20/12/2018
- Review Date: 31/12/2023
Associated Documents
- Form 57.014A – ICU Notification of Early Phase Clinical Trial
- Form 57.014B – ICU Notification of Early Phase Clinical Trial Contact Sheet
- Form 57.014C – Early Phase Clinical Trial Verification
- Guideline 57.014A – ICU Notification of Phase I Trial
SOP 57.016 – EDGE Clinical Research Management System
- Author Name: Kirsty McAinsh
- Version: 2.0
- Active Date: 19/10/2023
- Review Date: 31/12/2026
Associated Documents
- Form 57.016A – New User Request
- Guideline 57.016A – New User Access
- Guideline 57.016B – Creating New Study Record
- Guideline 57.016C – Importing Commercial Costing Template
- Guideline 57.016D – Non-commerical costing template
- Guideline 57.016E – New User Information
- Guideline 57.016F – EDGE Workflows
- Guideline 57.016G – EDGE Minimum Dataset
Chapter 58 – NHS GG&C Clinical Research Imaging Facility
SOP 58.001 – CRIF QEUH Adult Emergency Resuscitation Procedures
- Author Name: Tracey Hopkins
- Version: 3.0
- Active Date: 23/11/2023
- Review Date: 31/12/2026
Associated Documents
- Form 58.001A – CRIF QEUH Emergency Trolley Checklist
- Form 58.001B – CRIF Emergency Trolley signoff
SOP 58.002 – CRIF QEUH Paediatric Emergency Resuscitation Procedures
- Author Name: Tracey Hopkins
- Version: 3.0
- Active Date: 23/11/2023
- Review Date: 31/12/2026
Associated Documents
- None
SOP 58.004 – Clinical Research Involving Imaging
- Author Name: Tracey Hopkins
- Version: 3.0
- Active Date: 21/08/2023
- Review Date: 31/12/2026
Associated Documents
- Form 58.004A – Clinical Research Imaging Support Form
- Guideline 58.004A – Imaging Studies Approval Process
- Guideline 58.004C – Clinical Research Imaging Facility Administration
SOP 58.005 – CRIF Risk Assessment and Risk Mitigation
- Author Name: Tracey Hopkins
- Version: 3.0
- Active Date: 23/11/2023
- Review Date: 31/12/2026
Associated Documents
- Form 58.005A – Clinical Research Imaging Facility Study Risk Assessment Form
SOP 58.006 – Reporting of Research Images
- Author Name: Tracey Hopkins
- Version: 3.0
- Active Date: 21/08/2023
- Review Date: 31/12/2026
Associated Documents
- Guideline 58.006A – Reporting of Incidental Findings
SOP 58.008 – CRIF QEUH Controlled Access
- Author Name: Tracey Hopkins
- Version: 1.0
- Active Date: 23/11/2023
- Review Date: 31/12/2026
Associated Documents
- Form 58.008A – CRIF MRI Researcher Entitlement & Authorisation Application Form
- Guideline 58.008A – CRIF Researcher MRI Entitlement and Authorisation Guidelines
SOP 58.009 – CRIF Study Data and Document Management
- Author Name: Tracey Hopkins
- Version: 1.0
- Active Date: 23/11/2023
- Review Date: 31/12/2026
Associated Documents
- None
Investigator SOPs
There is a set reading list for Chief Investigators for Sponsored CTIMPs and CIMDs within NHSGGC which can be downloaded as a zip file below.
In addition, Principal Investigators within the Glasgow CRF must follow the relevant SOPs which can also be downloaded as a zip file below.
If you are both the Chief Investigator and the Principal Investigator for a GCRF site you will need to read both sets which may contain some overlap.